RecallWatchUSA

Home / Recalls / Medical Devices

Beckman Coulter, Inc. recalls MicroScan -Neg Breakpoint Combo Panel Type 34; Catalog number B1017-404; Panel MicroScan Neg Breakpoint 34 Neg panels

Recalled May 6, 2015 · FDA recall Z-1522-2015 · Beckman Coulter

Hazard
Siemens Healthcare Diagnostics has received complaints regarding panel degradation with a portion of the MicroScan Neg Breakpoint Combo 34 (NBP34) panel lot 2014-05-28. · FDA Class II
Units
681 boxes
Sold at
Worldwide Distribution - Nationwide Distribution including Puerto Rico and to the states of: KS, LA, MD, NY, WV,NM, NH, MO, CT, MA, OK, NC. IA, OH. WI, TX, PA, MS and MN and to the countries of : Canada, Kuwait, South Africa and Turkey.

Description

Siemens Healthcare Diagnostics has received complaints regarding panel degradation with a portion of the MicroScan Neg Breakpoint Combo 34 (NBP34) panel lot 2014-05-28.

Product
MicroScan -Neg Breakpoint Combo Panel Type 34; Catalog number B1017-404; Panel MicroScan Neg Breakpoint 34 Neg panels are designed for use in determining quantitative and /or qualitative antimicrobial agent susceptibility and /or identification to No.1 the species level of colonies, grown 34 on solid media, of rapidly growing aerobic and facultative anaerobic gram-positive bacteria
Manufacturer(s)
Beckman Coulter, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov